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Drug Interaction Statin

Information source: Bristol-Myers Squibb
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Coronary Syndromes

Intervention: BMS-919373 (Drug); Rosuvastatin (Drug); Atorvastatin (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

Summary

This purpose of this study is to assess the effects of BMS-919373 on the single dose Pharmacokinetics (PK) of Rosuvastatin and Atorvastatin in healthy subjects.

Clinical Details

Official title: A Phase 1 Open-label, Single-sequence Study to Evaluate the Effect of Coadministration of BMS-919373 on the Single-dose Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Subjects

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label

Primary outcome:

Maximum observed plasma concentration (Cmax) of Rosuvastatin and Atorvastatin

Area under the plasma concentration-time curve from time zero to 72 hours (AUC(0-72)) of Rosuvastatin and Atorvastatin

Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Rosuvastatin and Atorvastatin

Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin and Atorvastatin

Secondary outcome:

Time of maximum observed plasma concentration (Tmax) of Rosuvastatin and Atorvastatin

Terminal plasma half life (T-HALF) of Rosuvastatin and Atorvastatin

Apparent total body clearance (CLT/F) of Rosuvastatin and Atorvastatin

Safety based on results of physical examinations, vital sign measurements, ECGs, 24-hour telemetry, clinical laboratory tests, and physical measurements and will also include the incidence of AEs, SAEs and AEs leading to discontinuation

Detailed description:

Primary Purpose: Other - To assess the effects of BMS-919373 on the single dose PK of

Rosuvastatin and Atorvastatin in healthy subjects

Eligibility

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

For more information regarding BMS clinical trial participation, please visit www. BMSStudyConnect. com. Inclusion Criteria:

- Signed Written Informed Consent form

- Healthy subjects as determined by no clinically significant deviation from normal in

medical and surgical history, physical examination, physical measurements, vital signs, 12-lead ECG, 24-hour telemetry, and clinical laboratory tests

- Body mass index (BMI) of 18. 0 to 32. 0 kg/m2, inclusive

- Men and women, ages 18 to 55 yrs, inclusive

Exclusion Criteria:

- Current or history of cardiovascular diseases, including arrhythmias, coronary heart

disease, and congestive heart failure

- Current or history of symptomatic hypotension

- Current or history of liver diseases, including cirrhosis and liver failure

- Current or history of kidney diseases, including nephrotic syndrome, renal failure,

nephrolithiasis, and urolithiasis

- Current or history of neurological diseases, including presyncope, syncope,

convulsive disorders such as epilepsy, cerebral thrombosis and cerebral embolism, transient ischemic attack, and stroke; or mental disorders Exceptions for presyncope/syncope related to vasovagal responses are allowable at the discretion of the investigator

- History of significant head injury in the last 2 years

Locations and Contacts

Additional Information

Starting date: March 2014
Last updated: August 13, 2014

Page last updated: August 23, 2015

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